Principal Advanced Manufacturing Engineer - Mechanical - Ave Maria, FL. (Packaging)

Arthrex-posted 3 months ago
Full-time • Senior
FL
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Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is currently seeking a Principal Advanced Manufacturing Engineer to provide process engineering support to AMI Packaging Operations (Ex. Laser Mark/Weld, Passivation, Cleaning, Component/Device Assembly, Packaging, Boxing) and INC Product Design teams to achieve business goals. To lead the mechanical design and fabrication of custom semi-automated or fully automated manufacturing equipment, tooling and fixturing. To implement mechanical design solutions to improve safety, quality, and efficiency of manufacturing processes. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

  • Support a customer-focused culture by identifying key customer/user requirements and translating those into functional and design specifications during the design of custom equipment and fixturing.
  • Support a continuous improvement culture to enhance safety, quality, delivery, and cost by employing Lean/Six Sigma continuous improvement tools in all projects.
  • Support a highly innovative culture by identifying novel/first-of-a-kind solutions, and applying lessons learned through successes and failures.
  • Support a fast-paced, accountable, teamwork culture by completing project tasks on-time, identifying potential roadblocks, and effectively communicating status escalating issues.
  • Support new product development, design transfer, and continuous improvement (Kaizen) projects as the subject matter expert for equipment mechanical design and fabrication.
  • Maintain compliance with Safety requirements related to ergonomics (human-to-machine interface) and guarding.
  • Maintain compliance with Medical Device Quality System requirements related to equipment validation.
  • Design and develop mechanical design solutions for custom automation or semi-automated equipment or fixturing.
  • Design and develop custom poka yoke, Go/No-Go, and inspection gauges/fixtures as well as mechanical design of automated, inline inspection and test systems for electro-mechanical medical devices.
  • Identify and evaluate the optimum mechanical design solutions and equipment components based on the latest available technology and industry best practices.
  • Develop capital equipment project scope, budget, milestones, and follow a structured Management of Change process.
  • Provide requirements to equipment vendors (OEMs) and review design and specification packages during equipment quotation.
  • Create and execute validation protocols and reports compliant with Medical Device requirements (IQ, OQ, PQ).
  • Create Equipment maintenance manuals, recommend Preventive Maintenance Plans, and spare parts.
  • Create operator work instructions and troubleshooting guides.
  • Lead Root Cause Investigations or equipment troubleshooting using structured problem-solving tools (Lean A3, Six Sigma DMAIC) and Statistical Analysis.
  • Lead process development or process improvement work using process Failure Mode Analysis (pFMEA) and structured Design of Experiments (DOE’s).
  • Ensure data and documentation are consistently accurate and complete and in compliance with Good Documentation Practices (GDP).
  • May supervise Technician, Engineering, Prototype or Programming personnel.
  • B.S. in Engineering required
  • Minimum of 12 Yrs. experience in Design and Development or Manufacturing Engineering required.
  • Proven Experience leading process improvement projects.
  • Proven Experience leading new equipment, capital projects.
  • Experience leading/ supervising direct reports.
  • Experience in medical device manufacturing or other health sciences industry preferred.
  • SAP, miniTab, Solidworks experience preferred.
  • Lean Six Sigma Green Belt / Black Belt certification preferred.
  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)
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